A Preliminary Clinical Study on the Pharmacokinetics and Safety of CDP1 in Patients With Advanced CRC or HNSCC

OBJECTIVES: Primary: To compare the pharmacokinetic characteristics of a single dose between CDP1 and the original drug Erbitux In patients with advanced metastatic colorectal cancer. Secondary : 1. To compare the safety and immunogenic characteristics of the single dose between CDP1 and the original drug Erbitux in patients with advanced metastatic colorectal cancer. 2. To evaluate the pharmacokinetics and safety of CDP1 multiple administrations." OUTLINE The study can be divided into 3 parts: Part 1: Single-dose Phase: single center, parallel, randomized, single-blind trial. The original drug Erbitux as a control, CDP1 and Erbitux single-dose pharmacokinetics of the initial comparison, and at the same time safety and immunogen preliminary comparison. CDP1 group received a single administration of CDP1 250mg/m2, Erbitux group received Erbitux 250mg/m2 single administration. Two groups of subjects after a single administration into the 4-week observation period, safety observations, pharmacokinetic blood samples and immunogenic blood samples were collected. The tumor was evaluated at the end of the 4 week observation period.If the subjects did not develop the disease, or did not appear the intolerant toxicity during the observation period, they entered the period of multiple drug delivery. Part 2: Multi-dose Phase: Single center, single arm, open trial, evaluation of pharmacokinetics and safety with multiple doses of CDP1. Multiple administrations of two groups of subjects were followed by continuous administration of CDP1. Dosing regimen is the first administration of 400mg/m2, followed by 250mg/m2, once a week for 6 weeks. Part 3: Follow-up Phase: CDP1, IV, once a week, 250mg/m2, until the patient's death or the withdrawal decision of the patient and/or investigator.